Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour

Inclusion Criteria:

* Patients ≥18 years with selected metastatic solid tumours recognized to be highly vascularised and not amenable to any clinical improvement by current standard treatments

  * Colorectal cancer (CRC) patients previously resistant to standard systemic regimens (including biologic agents)
  * Gastric cancer (GC) patients treated with no more than two standard systemic regimens for metastatic disease
  * Hepatocellular carcinoma (HCC) patients previously resistant to standard systemic regimens
  * Pancreatic carcinoma (PC) patients treated with no more than one standard systemic regimen for metastatic disease
  * Non small cell lung carcinoma (NSCLC) patients treated with no more than two standard systemic regimens (including biologic agents) for metastatic disease
  * Neuroendocrine (NE) tumours refractory to somatostatin analogue treatment
  * Other rare tumours including malignant pleural mesothelioma (MPM), soft-tissue sarcoma (STS), and renal cell carcinoma (RCC), resistant/refractory to current standard treatments
* Life expectancy more than 3 months
* ECOG Performance status 0-1
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:

  * Neutrophils \>1.5 x 10\^9/L and platelets \> 100 x 10\^9/L
  * Bilirubin \<1.5 x ULN
  * AST and/or ALT \<2.5 x ULN in absence of liver metastasis
  * AST and/or ALT \<5 x ULN in presence of liver metastasis
  * Serum creatinine \<1.5 x ULN
  * Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
* Patients may have had prior therapy providing the following conditions are met before treatment start:

  * Chemotherapy, radiation therapy, hormonal therapy, or immunotherapy: wash-out period of 28 days
  * Surgery: wash-out period of 14 days
* Patients must give written informed consent to participate in the study.

Exclusion Criteria:

* Concurrent anticancer therapy
* Patients must not receive any other investigational agents while on study
* Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
* Uncontrolled hypertension
* Prolonged QTc interval (congenital or acquired) \> 450 ms
* Patient with significant peripheral vascular disease
* History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy), or history of stroke
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.